OSTEOGRAF/N-700

• K Number: K981214
• Device Name: OSTEOGRAF/N-700
• Manufacturer: CERAMED DENTAL, LLC.
• Date Cleared: 1998-06-26 ( 85 days)
• Product Code: LYC
• Regulation Number: 872.3930
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

The intended use of OsteoGraf/N-700 is for:

• Treatment of infrabony periodontal defects.
• Augmentation of bony defects of the alveolar ridge.
• Filling of extraction sites.
• Sinus elevation grafting.

Device Description

OsteoGraf/N-700 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite, the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 420-1000 microns.

AI/ML Overview

This 510(k) summary describes a medical device called OsteoGraf/N-700, which is a hydroxylapatite material intended for various dental and orthopedic bone-filling applications. The summary primarily focuses on characterizing the device and establishing its substantial equivalence to a predicate device (Bio-Oss).

The provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets and data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is a regulatory submission (510(k) summary) focused on device description, intended use, and comparison to a predicate device to demonstrate substantial equivalence, not on specific performance studies with acceptance criteria as typically seen for diagnostic or AI-driven devices.

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.